Healthcare Industry News: Alzheimer's disease
News Release - March 20, 2007
Myriad Genetics Completes Enrollment in Second Phase 3 Clinical Trial of Flurizan(TM) in Alzheimer's DiseaseSALT LAKE CITY, UT--(Healthcare Sales & Marketing Network)--Mar 20, 2007 -- Myriad Genetics, Inc. (NasdaqGS:MYGN ) (www.myriad.com) announced today that it has completed enrollment of patients in its global Phase 3 clinical trial of Flurizan(TM) (tarenflurbil) in Alzheimer's disease.
The global Phase 3 clinical trial, ActEarliAD, is a multinational, randomized, double-blind, placebo-controlled study of Flurizan in over 800 patients with mild Alzheimer's disease, who will be followed for 18 months. Patients enrolled in the study take 800 mg twice daily of either Flurizan or placebo and attend periodic physician visits for analysis of their performance on memory, cognition and behavioral tests. The two primary clinical endpoints of the trial are the change in cognitive decline and function, as measured by the Alzheimer's disease Assessment Scale -- cognitive subscale (ADAS-cog) and changes in activities of daily living, as measured by the Alzheimer's disease Cooperative Study -- Activities of Daily Living inventory (ADCS-ADL). A secondary endpoint of the trial is the change in overall function, measured by the Clinical Dementia Rating -- sum of boxes (CDR-sb) test. Additional exploratory outcome measures are designed to assess the psychological, physical and financial impact of this disease on caregivers and medical resources. The trial is designed to meet the requirements of the European Agency for the Evaluation of Medicinal Products, or EMEA, for marketing approval of Flurizan in Europe.
The primary endpoints in the global trial are identical to those of the U.S. Phase 3 trial and are the same as two of the three endpoints in the Phase 2 study. As was the case with the Phase 2 study, all patients in the Phase 3 studies are permitted to take current standard of care medicines in addition to Flurizan or placebo, provided their dose has been stable for six months. Therefore, benefits seen in the trials are in addition to any benefit provided by the current standard of care drugs. Myriad announced the completion of enrollment in the U.S. Phase 3 trial in August 2006.
Myriad conducted a double-blinded, placebo-controlled Phase 2 trial of Flurizan for 12 months duration in 207 patients with mild to moderate Alzheimer's disease. The study enrolled patients in the United Kingdom and Canada. After 12 months, patients with mild Alzheimer's disease in Canada were eligible to enroll in an additional double-blinded 12-month treatment study. The results of this study were presented in July 2006 at the 10th International Conference on Alzheimer's disease and Related Disorders, in Madrid, Spain. Additional results were presented earlier this month at the American Association for Geriatric Psychiatry in New Orleans, Louisiana.
Highlights of the Phase 2 Flurizan study include:
1. CDR-sb. A semi-structured interview with both the patient and caregiver, it is an overall (global) functional measure of Alzheimer's disease. A patient's performance is assessed in memory, orientation, judgment, problem solving, community activities, home and hobbies and personal care. Mild patients on 800 mg twice daily Flurizan showed a 72% reduced rate of decline (p=0.0005) at 24 months versus the placebo patient rate of decline over the first 12 months.
2. ADCS-ADL. A test completed by the patient's caregiver, it is a measure of the patient's ability to perform basic activities of daily living, such as dressing, eating, bathing and traveling. Mild patients on 800 mg twice daily Flurizan had a 67% (p=0.015) reduced rate of decline at 24 months in their ability to perform these activities, versus the placebo patient rate of decline over the first 12 months.
3. ADAS-cog. A test completed by the patient, it is a measure of a patient's performance in word recall, response to directions, ability to copy geometric forms, delayed word recall, ability to name objects, memory and quality of speech. It is the primary measure of memory and understanding used by regulatory authorities. Mild patients on 800 mg twice daily Flurizan showed a 52% (p=0.109) reduced rate of decline in these areas, versus the placebo patient rate of decline over the first 12 months.
4. MMSE. A test completed by the patient and administered by the physician, it is the standard clinical measure used by practicing physicians to assess, diagnose and monitor patients with Alzheimer's disease. Mild patients on 800 mg twice daily Flurizan showed a reduction in their rate of decline of 67% (p=0.001) in the Phase 2 follow-on trial, compared to the placebo patient rate of decline over the first 12 months
5. Time to Psychiatric Events (TPE). This measure assesses the time to the first psychiatric event such as aggression, depression, confusion and agitation. Delaying the time before a patient experiences these types of events or reducing the number of events may keep patients out of nursing care facilities. Patients on 800 mg twice daily Flurzan had fewer events (p=0.020) and those events were delayed by more than 227 days (p=0.011) compared to patients on placebo after 12 months in the Phase 2 study.
6. Dose Response. Plasma concentrations of Flurizan were significantly correlated with the size of the benefit to patients, so that the more Flurizan patients had in their blood, the more they benefited in reduction of decline on measures of Alzheimer's disease.
"Flurizan has been a well tolerated drug in the elderly in studies to date that total over 1,200 patient-years of safety data," said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "We are very pleased with the speed of the enrollment in the global Phase 3 trial and we look forward to confirming our belief that Flurizan can provide significant benefit to patients with mild Alzheimer's disease."
Flurizan (tarenflurbil) is the first in a new class of drugs known as Selective Amyloid Lowering Agents (SALAs).
Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The Company develops and markets molecular diagnostic products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on the Company's Web site at www.myriad.com.
Flurizan is a trademark of Myriad Genetics, Inc. in the United States and other countries.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include: the study and completion of the Phase 3 clinical trial for 18 months; the design and ability of additional exploratory outcome measures to assess the psychological, physical and financial impact of disease on caregivers and medical resources; the design of the trial to meet the requirements of the European Agency for the Evaluation of Medicinal Products for marketing approval of Flurizan in Europe; and our belief that Flurizan can help patients with mild Alzheimer's disease. These forward-looking statements are based on management's current expectation and are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth or implied by forward-looking statements. These include, but are not limited to, uncertainties as to the extent of future government regulation of Myriad Genetics' business; uncertainties as to whether Myriad Genetics and its collaborators will be successful in developing, and obtaining regulatory approval for, and commercial acceptance of, therapeutic compounds; the risk that markets will not exist for therapeutic compounds that Myriad Genetics develops or if such markets exist, that Myriad Genetics will not be able to sell compounds, which it develops, at acceptable prices; and the risk that the Company will not be able to sustain revenue growth for its predictive medicine business and products. These and other risks are discussed under the heading "Risk Factors" contained in Item 1A in our Annual Report on Form 10-K for the year ended June 30, 2006, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of this release, and Myriad undertakes no duty to update this information unless required by law.
Source: Myriad Genetics
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